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. Author manuscript; available in PMC: 2022 Nov 15.
Published in final edited form as: N Engl J Med. 2022 Apr 2;386(19):1781–1792. doi: 10.1056/NEJMoa2201295

Table 2.

Primary and Safety Outcomes.

Outcome Imputation Analysis (N = 2408)* Complete-Case Analysis (N = 2325)
Adjusted Risk Ratio (95% CI) P Value Active Treatment Control Risk Ratio (95% CI) P Value
no./total no. (%)
Primary composite outcome 0.82 (0.74–0.92) <0.001 353/1170 (30.2) 427/1155 (37.0) 0.82 (0.73–0.92) <0.001

    Preeclampsia with severe features 0.80 (0.70–0.92) 272/1170 (23.3) 336/1155 (29.1) 0.80 (0.70–0.92)

    Medically indicated preterm birth at <35 wk 0.73 (0.60–0.89) 143/1170 (12.2) 193/1155 (16.7) 0.73 (0.60–0.89)

    Placental abruption 0.88 (0.49–1.59) 20/1170 (1.7) 22/1155 (1.9) 0.90 (0.49–1.64)

    Fetal or neonatal death at <28 days 0.81 (0.54–1.22) 41/1170 (3.5) 50/1155 (4.3) 0.81 (0.54–1.21)

Safety outcome

    Small for gestational age

   <10th percentile 1.04 (0.82–1.31) 0.76 128/1146 (11.2) 117/1124 (10.4) 1.07 (0.85–1.36) 0.56

   <5th percentile 0.89 (0.62–1.26) 0.51 58/1146 (5.1) 62/1124 (5.5) 0.92 (0.65–1.30) 0.63
*

Shown are the results of multiple imputation analysis performed with the use of multivariable log-binomial regression models to calculate adjusted risk ratios. The missing values were modeled within treatment group with the use of baseline characteristics that included diabetes status (yes or no), treatment status at enrollment (receiving or not receiving blood-pressure medication), age, body-mass index, and elevated blood pressure (≥150 mm Hg systolic or ≥100 mm Hg diastolic) at the first visit.

Complete-case analysis of the primary outcome included 2325 patients with sufficient data (1170 in the active-treatment group and 1155 in the control group). Complete-case analysis of the safety outcome included 2270 patients with sufficient data (1146 in the active-treatment group and 1124 in the control group); included in this analysis were assessments of data obtained during delivery.